Last reviewed · How we verify

NCT05169801

To Compare the Efficacy and Safety of BP102 vs. Avastin® in Combination With Paclitaxel/Carboplatin in First-line Treatment of Advanced or Relapsed NSCLC

Completed Phase 3 Last updated 27 December 2021
What this trial tests

Phase 3 trial testing BP102, paclitaxel, carboplatin in Non-small Cell Lung Cancer(NSCLC) in 520 participants. Completed in 17 June 2021.

Timeline
25 January 2018
Primary endpoint
21 October 2019
17 June 2021

Quick facts

Lead sponsorJiangsu HengRui Medicine Co., Ltd.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment520
Start date25 January 2018
Primary completion21 October 2019
Estimated completion17 June 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jiangsu HengRui Medicine Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Non-small Cell Lung Cancer(NSCLC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, double-blind, positive parallel control, multicentre Phase III clinical trial, a clinical trial of biosimilar drugs, so the type of comparison is equivalence test.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Trial watch: chemotherapy-induced immunogenic cell death in oncology.
    Sprooten J, Laureano RS, Vanmeerbeek I, Govaerts J, et al · · 2023 · cited 59× · PMID 37284695 · DOI 10.1080/2162402x.2023.2219591
  2. Monoclonal antibody biosimilars for cancer treatment.
    Broer LN, Knapen DG, de Groot DA, Mol PGM, et al · · 2024 · cited 4× · PMID 38974466 · DOI 10.1016/j.isci.2024.110115
  3. Biosimilar monoclonal antibodies for cancer treatment in adults.
    Galvao TF, Livinalli A, Lopes LC, Zimmermann IR, et al · · 2024 · cited 2× · PMID 39607013 · DOI 10.1002/14651858.cd013539.pub2

Verify or expand the search:

Other Jiangsu HengRui Medicine Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05169801.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing